FDA extends Inbrija NDA review period

14 September 2018

The US Food and Drug Administration has extended the Prescription Drug User Fee Act (PDUFA) goal date for its review of the New Drug Application (NDA) of Parkinson’s disease candidate Inbrija (levodopa inhalation powder) from October 5, 2018 to January 5, 2019.

This marks another setback for Acorda Therapeutics (Nasdaq: ACOR), the drug’s developer, which in August 2017 received a Refusal to File (RTF) letter regarding the drug from the FDA. Last November, the company also gave up on its tozadenant for Parkinson's disease, days after the company’s Phase III trial program was effectively halted due to worrying safety data.

The latest news also comes just days after the company lost its appeal of a court decision invalidating four patents protecting its multiple sclerosis treatment Ampyra (dalfampridine).

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